NCT00382720|CompletedPhase 2Results

Docetaxel and Oxaliplatin in Gastric Cancer

A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease

Sanofi ClinicalTrials.gov

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2 other identifiers

DOCOX_C_00082EudraCT # : 2005-005464-92

Study Type

interventional

Target

275

Locations

12 countries

Sites

Timeline

RegisteredSep 2006

StartedSep 2006

CompletionApr 2010

Brief Summary

This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population. Primary objective:

To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II). Secondary objectives:
To establish the safety profile.
To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria
To assess the Overall Survival (OS)

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

275

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Sep 2006

Typical duration for phase_2

Geographic Reach

12 countries

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.6 years study duration

Study Start

First participant enrolled

September 1, 2006

Completed

26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

August 10, 2011

Completed

Last Updated

January 7, 2013

Status Verified

December 1, 2012

Enrollment Period

3.6 years

First QC Date

September 27, 2006

Results QC Date

April 29, 2011

Last Update Submit

December 19, 2012

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

Time to Progression
The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause. WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion.
every 8 weeks up to a maximum of 36 months

Secondary Outcomes (2)

Best Overall Response Rate (ORR)
every 8 weeks up to a maximum of 36 months
Overall Survival (OS)
up to a maximum of 36 months

Study Arms (3)

TE (Taxotere and Eloxatin)

EXPERIMENTAL

Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin). Each chemotherapy cycle was repeated every 21 days. Participants received either the optimal or non-optimal dose for Taxotere and Eloxatin. Participants who received the optimal dose for Taxotere and Eloxatin were analyzed in this study.

Drug: Docetaxel + Oxaliplatin

TEF (Taxotere, Eloxatin and 5-FU)

EXPERIMENTAL

Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and 5-FU (5-Fluorouracil). Each chemotherapy cycle was repeated every 14 days. Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and 5-FU. Participants who received the optimal dose for Taxotere, Eloxatin and 5-FU were analyzed in this study.

Drug: Docetaxel + Oxaliplatin + 5-FU

TEX (Taxotere, Eloxatin and Xeloda)

EXPERIMENTAL

Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and capecitabine (Xeloda). Each chemotherapy cycle was repeated every 21 days. Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and Xeloda. Participants who received the optimal dose for Taxotere, Eloxatin and Xeloda were analyzed in this study.

Drug: Docetaxel + Oxaliplatin + Capecitabine

Interventions

Docetaxel + OxaliplatinDRUG

Dose level 1 (non-optimal dose): Docetaxel 75 mg/m² as an 1-hour intravenous (IV) infusion on day 1 followed by Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1 Dose level 2 (optimal dose): Docetaxel 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin 130 mg/m² as a two to six-hour IV infusion on day 1

TE (Taxotere and Eloxatin)

Docetaxel + Oxaliplatin + 5-FUDRUG

Dose level 1 (non-optimal dose): Docetaxel 40 mg/m² as a 1-hour intravenous (IV) infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m2 as a 46-hour continuous infusion day 1. Dose level 2 (optimal dose): Docetaxel 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1.

TEF (Taxotere, Eloxatin and 5-FU)

Docetaxel + Oxaliplatin + CapecitabineDRUG

Dose level 1 (optimal dose): Docetaxel 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m2 two times a day continuously. Dose level 2 (non-optimal dose): Docetaxel 65 mg/m² as a 1-hour IV infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m² two times a day continuously.

TEX (Taxotere, Eloxatin and Xeloda)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically proven gastric adenocarcinoma, including adenocarcinoma of the gastro-oesophageal junction
Metastatic or locally recurrent disease
Prior adjuvant (and/or neo-adjuvant) chemotherapy with 5-Fluorouracil, Cisplatin, epirubicin is allowed provided that the patient has relapsed \> 12 months after the end of the chemotherapy
Performance status Karnofsky index \> 70
Hematology within 7 days before randomization:Hemoglobin ≥10g/dl, Absolute Neutrophil Count ≥2.0 10\^9/L, platelets ≥100 x 10\^9/L
Blood chemistry within 7 days before randomization:Total bilirubin ≤1x Upper Normal Limit(UNL), Aspartate Aminotransferase (AST) Serum Glutamic Oxaloacetic Transaminase SGOT) and Alanine Aminotransferase (ALT)Serum Glutamate Pyruvate Transaminase(SGPT) ≤2.5xUNL, alkaline phosphatase ≤ 5x UNL, provided that AST or ALT \> 1.5 x UNL is not associated with alkaline phosphatase \> 2.5 x UNL; creatinine ≤1.25x UNL or 1.25x UNL \< creatinine ≤1.5x UNL and calculated/measured creatinine clearance ≥60 ml/min)
Measurable and/or evaluable metastatic disease

You may not qualify if:

Any prior palliative chemotherapy
Neurosensory symptoms National Cancer Institute Common Toxicity Criteria for Adverse Events grade≥2
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.